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Director Clinical Study Leader, HBS Specialist, Oncology R&D, Early Oncology Clinical

Plats Gaithersburg, Maryland, USA Waltham, Massachusetts, USA Jobb-id R-197349 Datum inlagd 04/15/2024

Introduction to role:

Join us in our mission to eliminate cancer as a cause of death. As the Director Study Leader Human Biological Sample (HBS) Specialist in Early Oncology Clinical (EOC), you will be responsible for delivering complex studies and managing best practices across EOC for HBS. This role requires a high degree of flexibility and autonomy, with potential opportunities for program level responsibilities. You may also provide expert input to other non-drug programs and improvement projects. 


As a Director Study Leader, you will provide expert clinical operational input into project or study level documents, lead the delivery of clinical studies from concept to final CSR, and ensure timely delivery to quality, budget and time. You will also be responsible for planning and leading issue escalation and resolution, forecasting and management of study delivery costs, resource and timelines, and oversight of CROs and other clinically outsourced third party vendors for outsourced studies. Expert in RTSM acting as a tactical and strategic partner to both study teams and GCS

Crucial Skills/Experience:

  • Bachelor’s degree in related discipline, preferably in medical or biological science.
  • At least 10 years drug development experience demonstrated in a variety of roles.
  • At least 5 years of experience in leading studies in clinical development.
  • Extensive knowledge of the clinical and pharmaceutical drug development process.
  • Extensive and proven experience in driving operational delivery to timelines, cost and quality.
  • Proven experience leading delivery through internal and external organizations.
  • Project Management experience within the context of Clinical Drug Development.
  • Experience and strength in working and leading in matrix teams.
  • Strong collaborative communications skills including the ability to engage with a diverse client base and manage through conflict.
  • Proven track record in problem solving and issues management that is solution focused.

Desirable Skills/Experience:

  • Higher degree e.g. PhD, MSc, MPhil.
  • Programme management qualification (e.g. MBA, PRINCE2).
  • Experience in variety of academic/CRO/Sponsor organisations and countries.
  • Early oncology clinical delivery.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Why AstraZeneca?
At AstraZeneca's Oncology R&D, we push the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer. With one of the broadest and deepest Oncology pipelines in the industry, there are many opportunities to work with new and novel drugs and help discover what's next. We foster a mindset of courage, where everyone is empowered to step up, innovate and work at pace. We lead through true collaboration, building collective wisdom by giving everyone a chance to input. It's science with an impact-making a difference for patients and people around the world.

Take a crucial inter-disciplinary approach to save patients' lives! Work at the forefront by taking an inter-disciplinary approach including novel biomarkers, AI, novel endpoints and cutting-edge trial designs. It's because we are constantly innovating that we are able to develop life-changing medicines, change the way cancer is treated and ultimately improve outcomes for patients everywhere.

Ready to make a difference? Apply now and join us in our mission to eliminate cancer as a cause of death.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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